UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016674
Receipt No. R000019098
Scientific Title Diagnosis of Helicobacter pylori Gastritis by esophagogastroduodenoscopy (EGD)
Date of disclosure of the study information 2015/03/01
Last modified on 2020/03/05 (Ver. 6)

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Basic information
Public title Diagnosis of Helicobacter pylori Gastritis
by esophagogastroduodenoscopy (EGD)
Acronym Diagnosis of Helicobacter pylori Gastritis
by EGD
Scientific Title Diagnosis of Helicobacter pylori Gastritis
by esophagogastroduodenoscopy (EGD)
Scientific Title:Acronym Diagnosis of Helicobacter pylori Gastritis
by EGD
Region
Japan

Condition
Condition Helicobacter pylori Gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of diagnosis of Helicobacter pylori Gastritis by esophagogastroduodenoscopy (EGD)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the accuracy of Helicobacter pylori Gastritis by esophagogastroduodenoscopy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who were explained about the study and gave a written informed consent.
Key exclusion criteria 1. Advanced gastric cancer
2. History of gastric surgery
3. treatment of proton pump inhibitor, or histamine antagonist
4. Severe renal dysfunction
5. Pregnant women
6. Patients who were disqualified for the study by their physicians.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Mototsugu
Middle name
Last name Kato
Organization Hokkaido University Hospital
Division name Department of Endoscopy
Zip code 0608648
Address N14,W5,Kita-ku,Sapporo,Hokkaido
TEL 011-716-1161
Email m-kato@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Shinji
Middle name
Last name Yoshii
Organization SAPPORO MEDICAL CENTER, NTT EC
Division name Department of Gastroenterology
Zip code 0600061
Address S1,W15,Chuo-ku,Sapporo,Hokkaido
TEL 011-623-7000
Homepage URL
Email shinji-yoshii@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization SAPPORO MEDICAL CENTER, NTT EC
Address S1,W15,Chuo-ku,Sapporo,Hokkaido
Tel 0116237000
Email shinji-yoshii@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019098
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/den.13486
Number of participants that the trial has enrolled 498
Results 
Significantly higher diagnostic odds were obtained for
RAC (32.2), FGP (7.7), and red streak (4.7) in subjects with noninfection,
map-like redness (12.9) in subjects with past infection,
and diffuse redness (26.8), mucosal swelling (13.3), sticky mucus
(10.2) and enlarged fold (8.6) in subjects with current infection.
The overall diagnostic accuracy rate was 82.9% with the Kyoto
classification of gastritis.
Results date posted
2020 Year 03 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
In this prospective study, 498 subjects were
recruited. Seven well-experienced endoscopists blinded to the
history of eradication therapy performed the examinations.
Participant flow 
In this prospective study, 498 subjects were
recruited. Seven well-experienced endoscopists blinded to the
history of eradication therapy performed the examinations.
Adverse events 
none
Outcome measures 
The correlation of each of the 16 endoscopic features with
the three H. pylori infection statuses (current infection, noninfection,
past infection) was analyzed. Sensitivity, specificity,
positive predictive value (PPV), negative predictive
value (NPV), and diagnostic odds ratio (DOR)19 were
calculated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
2014 Year 12 Month 14 Day
Anticipated trial start date
2015 Year 01 Month 07 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 09 Month 01 Day

Other
Other related information comparison of machine learning and endoscopic diagnosis

Management information
Registered date
2015 Year 03 Month 01 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019098